Label: GENEXA ANTACID MAXIMUM STRENGTH- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Calcium carbonate USP 1000 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses relieves

    • heartburn
    • acid indigestion
    • sour stomach
    • upset stomach associated with these symptoms
  • WARNINGS

    Warnings

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 7 tablets in 24 hours
    • if pregnant, do not take more than 5 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor

  • STORAGE AND HANDLING

    Other information

    • each tablet contains: elemental calcium 400 mg
    • store between 20-25°C (68-77°F) in a dry place out of direct sunlight
  • INACTIVE INGREDIENT

    Inactive ingredients organic beet root, organic carnauba wax, non-GMO dextrose, organic flavors, organic maltodextrin, organic rice bran extract

  • QUESTIONS

    Questions?1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    Bottle is safety sealed with a seal under cap. DO NOT use if bottle seal is disturbed or missing.

    *This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare (US) Private LLC, owner of the registered trademark TUMS® Ultra Strength 1000 Assorted Berries.

    Patent Pending | Distributed by: Genexa Inc., Atlanta, GA 30324

    genexa.com

    Made in the USA with globally sourced ingredients

    R-20230303

    NDC 69676-0072-4

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    MEDICINE MADE CLEAN

    Antacid Maximum Strength

    Calcium Carbonate 1000 mg

    Heartburn

    Acid Indigestion

    Upset Stomach

    Compare to active ingredient in TUMS® Ultra Strength 1000 Assorted Berries*

    Medicine made clean

    Same effective active ingredient, but no artificial fillers.

    Organic Berry & Vanilla Flavor

    72 Chewable Tablets

    16A_Antacid_PDP_Label_R-20230303

    16A_Antacid_Back_Label_R-20230303

  • INGREDIENTS AND APPEARANCE
    GENEXA ANTACID  MAXIMUM STRENGTH
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0072
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    BEET (UNII: N487KM8COK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    RICE BRAN (UNII: R60QEP13IC)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize19mm
    FlavorBERRY, VANILLAImprint Code G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0072-472 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/26/2022
    Labeler - Genexa Inc. (079751024)
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